GUEST CONTRIBUTORS

  • Unpacking The Latest Brexit Developments And Their Potential Impact On Pharma
    Unpacking The Latest Brexit Developments And Their Potential Impact On Pharma

    With less than a year to go until the March 31, 2019 divorce date for the U.K. and the EU, one would be forgiven for thinking there would already be a plan in place to deal with an event that will have such a profound global impact on the pharmaceutical industry. However, manufacturers still seemingly have to prepare for any possibly scenario, while continuing to wait for clarity.

  • Determining Significant Vs. Nonsignificant Risk In Medical Devices
    Determining Significant Vs. Nonsignificant Risk In Medical Devices

    Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.

  • Best Practices In Environmental Monitoring Sampling — Transportation & Analysis
    Best Practices In Environmental Monitoring Sampling — Transportation & Analysis

    The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases to increase the likelihood of success during inspection for licensure of a facility. This article discusses the final two phases.

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PHARMA OUTSOURCING WHITE PAPERS

Choosing The Best Sterile Dosage Form For Your Phase I  Clinical Supply Needs Choosing The Best Sterile Dosage Form For Your Phase I Clinical Supply Needs

When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages. With careful planning and strategic foresight, these advantages can be leveraged to great effect during the development program. Read the whitepaper to learn more.

In-House Versus Outsource: A Decision-Making Guide In-House Versus Outsource: A Decision-Making Guide

Biopharmaceutical executives must consider how outsourcing fits into their development and production strategy, as well as how to select the best CDMO partner for their business. Here’s a step-by-step guide to help make that decision.

Multiplexing: Managing Risk With Proven, Single-Use Solutions

With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

On Target With Antibody Drug Conjugates

Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

Managing Demand Uncertainty In Biologics Production

How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Efficient, High-Titer Monoclonal Antibody Production In A Fed-Batch Process

This application note shows the feasibility of monoclonal antibody (MAb) production in fed-batch processes using the single-use Xcellerex™ XDR-200 stirred-tank and ReadyToProcess WAVE™ 25 rocking bioreactor systems.

Screening Of Loading Conditions On Capto S Using A New High-Throughput Format, PreDictor Plates

Finding the optimal conditions for a downstream purification process is of critical importance to gain high productivity and to achieve a robust biopharmaceutical manufacturing process at large scale

Efficiency Test Of ReadyToProcess™ Columns

ReadyToProcess™ columns are prepacked, prequalified, and presanitized process chromatography columns suited for purification of biopharmaceuticals (e.g., proteins, vaccines, plasmids, and viruses) for clinical phase I and II studies. ReadyToProcess columns are available with several media at different volumes (1, 2.5, 10, and 20 L).

Achieve Continuous Supply Of Drug Treatment For Study Requirements

A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Pediatric Clinical Trials: Special Considerations and Requirements June 4 - 4, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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